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The efficacy and safety of Lactulose vs. polyethylene glycol on high-risk bowel preparation population: a single-center randomized controlled trial

The efficacy and safety of Lactulose vs. polyethylene glycol on high-risk bowel preparation population: multi-center randomized controlled trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108144
Enrollment
Unknown
Registered
2025-08-25
Start date
2025-04-02
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk bowel preparation

Interventions

Lactulose group :Lactulose
Polyethylene glycol group:Polyethylene glycol

Sponsors

The Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Individuals aged 18 years and above who require colonoscopy. 2. Presence of any one of the following risk factors for bowel preparation: age >70 years, chronic constipation, Parkinson's disease, history of stroke or spinal cord injury (spinal cord injury from spinal disease history), previous inadequate bowel preparation, history of hypotension, body mass index (BMI) >25 kg/m^2, and use of tricyclic antidepressants or anesthetics.

Exclusion criteria

Exclusion criteria: 1. Individuals with contraindications to colonoscopy; 2. Patients with galactosemia; 3. Those allergic to lactulose or compound polyethylene glycol; 4. Pregnant or lactating women; 5. Individuals who have taken laxatives or gastrointestinal prokinetic drugs within 1 week; 6. Diabetic patients; 7. Patients with poor food intake and significant insufficient fluid/energy intake; 8. Those unable or unwilling to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Boston score;Detection rate of polyps and adenomas;Blood osmotic pressure level ;

Secondary

MeasureTime frame
Insertion and withdrawal time of endoscope ;Adverse reaction;

Countries

China

Contacts

Public ContactJiang Yong

The Second Hospital of Tianjin Medical University

jiangyong-612@163.com+86 139 2030 9608

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026